European urology focus · 2025
The STent Or NEphrostomy Study: A Randomised Controlled Trial Evaluating the Effectiveness of Percutaneous Nephrostomy Versus Internal Stent in Patient with Urolithiasis and an Indication for Decompression.
СтатьяРандомизированное исследованиеEquivalence TrialСравнительное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Hendriks Nora, Schuil Hugo W, Duijnhoven Ruben G, Oskam Bart C H, Arends Tom J H, Duijvesz Diederick, Horsch Alexander D, van der Heij Bart, Tjiam Irene, van Overhage Hans, Lamers Armand B G N, van Delden Otto M, Scheepens Wout, Drossaerts Jamie M A, d'Ancona Frank C H, Boering Steven, van Uhm Janneke I M, van der Meer Rutger W, van Roijen Herman J H, de Kiefte Martin, Hendrix Ad, Weltings Saskia, Pelger Rob C M, Beerlage Harrie P, Kamphuis Guido M, Schout Barbara M A
Аннотация
BACKGROUND AND OBJECTIVE: Obstruction by urolithiasis may be the reason for a percutaneous nephrostomy (PCN) or the placement of an internal stent. High-quality evidence is scarce. The objective of this study is to investigate whether a PCN is noninferior to an internal stent with regard to effectiveness (time to clinical recovery).
METHODS: In this nationwide randomised controlled noninferiority trial performed in 11 secondary and tertiary care hospitals in the Netherlands, we randomised 204 patients for either a PCN or an internal stent. The primary outcome was the time to recovery.
KEY FINDINGS AND LIMITATIONS: Baseline characteristics were comparable. Fourteen participants crossed over from the PCN group to the internal stent group, of whom most (n = 11) crossed over due to technical failure, as opposed to four crossovers from the internal stent group to the PCN group. The mean time to recovery was 1.7 d (standard deviation [SD] 1.7) in the PCN arm and 1.5 d (SD 1.5) in the internal stent group. The mean difference was 0.3 (95% confidence interval -0.2 to 0.7) and did not exceed the noninferiority margin of 1 d (noninferiority p < 0.01). No statistically significant difference was observed in the percentage of participants with adverse events, nor were we able to demonstrate a statistically significant difference in the number of events of Clavien-Dindo grade ≥3a. The current study revealed a notably high rate of crossovers due to technical failure.
CONCLUSIONS AND CLINICAL IMPLICATIONS: The STent Or NEphrostomy study proved a PCN to be noninferior to an internal stent in terms of the time to clinical recovery. Either option for drainage is an effective method of treatment, as long as patient-specific risk factors for technical failure of the procedure are considered.
METHODS: In this nationwide randomised controlled noninferiority trial performed in 11 secondary and tertiary care hospitals in the Netherlands, we randomised 204 patients for either a PCN or an internal stent. The primary outcome was the time to recovery.
KEY FINDINGS AND LIMITATIONS: Baseline characteristics were comparable. Fourteen participants crossed over from the PCN group to the internal stent group, of whom most (n = 11) crossed over due to technical failure, as opposed to four crossovers from the internal stent group to the PCN group. The mean time to recovery was 1.7 d (standard deviation [SD] 1.7) in the PCN arm and 1.5 d (SD 1.5) in the internal stent group. The mean difference was 0.3 (95% confidence interval -0.2 to 0.7) and did not exceed the noninferiority margin of 1 d (noninferiority p < 0.01). No statistically significant difference was observed in the percentage of participants with adverse events, nor were we able to demonstrate a statistically significant difference in the number of events of Clavien-Dindo grade ≥3a. The current study revealed a notably high rate of crossovers due to technical failure.
CONCLUSIONS AND CLINICAL IMPLICATIONS: The STent Or NEphrostomy study proved a PCN to be noninferior to an internal stent in terms of the time to clinical recovery. Either option for drainage is an effective method of treatment, as long as patient-specific risk factors for technical failure of the procedure are considered.